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Post-finasteride syndrome

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Post-Finasteride Syndrome describes a range of sexual, physical and neurological side effects that are reported to persist and develop after cessation of the 5-alpha reductase inhibitor Finasteride. Adverse drug reactions reported in association with finasteride are dose independent and more common, numerous and severe in younger patients using the 1mg dose to prevent androgenic alopecia.

Preclinical evidence demonstrates interference by 5alpha-reductase inhibitors in sexual, cognitive and physical domains relevant to reported persistent symptoms. The existence of the condition is often considered controversial, owing to both the underlying biological mechanism and the incidence of the condition being unclear. A lack of clear diagnostic criteria and the variable reporting fraction in different health-care settings make the problem challenging to evaluate.

Symptoms

Symptoms of Post-Finasteride syndrome include penile atrophy and tissue changes, decreased ejaculate volume and quality, libido loss, erectile dysfunction, dry skin, metabolic changes, muscle and strength loss, anxiety, panic attacks, insomnia, anhedonia, concentration problems, memory impairment and suicidal ideation.

Clinical Findings

Case-control study of symptomatic post-finasteride syndrome patients has revealed significantly higher expression of the androgen receptor in penile skin, alterations in levels of neuroactive steroids, and markers of neuropathy of the pudendal nerve.(CAG)n and (GGN)n repeat lengths in the AR gene have been correlated to the symptoms reported by PFS patients. PFS patients have also been found to exhibit neural abnormalities as assessed by functional magnetic resonance imaging.

Cause

The rarity, variability and dose independence of the syndrome has been hypothesised to depend upon epigenetic phenotype. Finasteride-induced epigenetic changes in gene expression, including upregulation of the androgen receptor, may result in undesirable biological outcomes such as impairment of dopaminergic signalling and modulation of other neurotransmitter receptors, causing persistent or permanent adverse effects.

A dermatologist suggested an alternative hypothesis of mass delusion.

Controversy

Adverse event reports have increased over time, leading to suggestions of a potential nocebo effect. However, significant adverse event reported signals were determined to exist before and after 2011, irrespective of the public’s knowledge of sexual dysfunction as a safety concern associated with finasteride.

Of 34 clinical trials assessing the safety of finasteride for use in androgenic alopecia, meta-analysis concluded that none were found to have had adequate safety reporting.

A 2019 Reuters investigation revealed that Merck, the manufacturer of Propecia, had found evidence of persistent side effects in their original clinical trials and chose not to disclose it in their original warning label. Use of the drug by younger men for hair loss has also been associated with reports of suicidality and completed suicide.

References

  1. ^ Than, Jeffrey K.; Rodriguez, Katherine; Khera, Mohit (2018-09-01). "Post-finasteride Syndrome: A Review of Current Literature". Current Sexual Health Reports. 10 (3): 152–157. doi:10.1007/s11930-018-0163-4. ISSN 1548-3592.
  2. ^ Traish, Abdulmaged M. (2020-01-01). "Post-finasteride syndrome: a surmountable challenge for clinicians". Fertility and Sterility. 113 (1): 21–50. doi:10.1016/j.fertnstert.2019.11.030. ISSN 0015-0282. PMID 32033719.
  3. ^ Frye, Cheryl A.; DaCosta, Dan; Lembo, Vincenzo F.; Walf, Alicia A. (2020-12-01). "Advances in Knowledge of Androgens: How Intentional and Accidental Neurosteroid Changes Inform Us of Their Action and Role". Current Sexual Health Reports. 12 (4): 209–220. doi:10.1007/s11930-020-00276-2. ISSN 1548-3592.
  4. Harrell, Matthew B.; Ho, Kaylee; Te, Alexis E.; Kaplan, Steven A.; Chughtai, Bilal (2020-06-28). "An evaluation of the federal adverse events reporting system data on adverse effects of 5-alpha reductase inhibitors". World Journal of Urology. doi:10.1007/s00345-020-03314-9. ISSN 1433-8726.
  5. Baas, Wesley R.; Butcher, Michael J.; Lwin, Aye; Holland, Bradley; Herberts, Michelle; Clemons, Joseph; Delfino, Kristin; Althof, Stanley; Kohler, Tobias S.; McVary, Kevin T. (2018-10-01). "A Review of the FAERS Data on 5-Alpha Reductase Inhibitors: Implications for Postfinasteride Syndrome". Urology. 120: 143–149. doi:10.1016/j.urology.2018.06.022. ISSN 0090-4295. PMID 29960004.
  6. ^ Walf, Alicia A.; Kaurejo, Shan; Frye, Cheryl A. (2018-07-01). "Research Brief: Self-Reports of a Constellation of Persistent Antiandrogenic, Estrogenic, Physical, and Psychological Effects of Finasteride Usage Among Men". American Journal of Men's Health. 12 (4): 900–906. doi:10.1177/1557988317750989. ISSN 1557-9883. PMC 6131463. PMID 29318957.{{cite journal}}: CS1 maint: PMC format (link)
  7. Gray, Shelly L.; Semla, Todd P. (2019-08-09). "Post-finasteride syndrome". BMJ. 366: l5047. doi:10.1136/bmj.l5047. ISSN 0959-8138. PMID 31399423.
  8. ^ Maksym, Radosław B.; Kajdy, Anna; Rabijewski, Michał (2019-10-02). "Post-finasteride syndrome – does it really exist?". The Aging Male. 22 (4): 250–259. doi:10.1080/13685538.2018.1548589. ISSN 1368-5538. PMID 30651009.
  9. ^ Traish, Abdulmaged M. (2018-09-01). "The Post-finasteride Syndrome: Clinical Manifestation of Drug-Induced Epigenetics Due to Endocrine Disruption". Current Sexual Health Reports. 10 (3): 88–103. doi:10.1007/s11930-018-0161-6. ISSN 1548-3592.
  10. Patisaul, Heather B.; Belcher, Scott M. (2017-05-18). Receptor and Enzyme Mechanisms as Targets for Endocrine Disruptors. Vol. 1. Oxford University Press. doi:10.1093/acprof:oso/9780199935734.003.0005.
  11. "Post-finasteride syndrome: An emerging clinical problem". Neurobiology of Stress. 12: 100209. 2020-05-01. doi:10.1016/j.ynstr.2019.100209. ISSN 2352-2895.
  12. Ali, Ayad K.; Heran, Balraj S.; Etminan, Mahyar (2015). "Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study". Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 35 (7): 687–695. doi:10.1002/phar.1612. ISSN 1875-9114.
  13. Belknap, Steven M.; Aslam, Imran; Kiguradze, Tina; Temps, William H.; Yarnold, Paul R.; Cashy, John; Brannigan, Robert E.; Micali, Giuseppe; Nardone, Beatrice; West, Dennis P. (2015-06-01). "Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia". JAMA Dermatology. 151 (6): 600. doi:10.1001/jamadermatol.2015.36. ISSN 2168-6068.
  14. "U.S. court let Merck hide secrets about popular drug's risks". Reuters. Retrieved 2021-03-25.
  15. Terhune, Dan Levine, Chad (2021-02-03). "Exclusive: Merck anti-baldness drug Propecia has long trail of suicide reports, records show". Reuters. Retrieved 2021-03-25.{{cite news}}: CS1 maint: multiple names: authors list (link)
  16. Nguyen, David-Dan; Marchese, Maya; Cone, Eugene B.; Paciotti, Marco; Basaria, Shehzad; Bhojani, Naeem; Trinh, Quoc-Dien (2021-01-01). "Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride". JAMA Dermatology. 157 (1): 35–42. doi:10.1001/jamadermatol.2020.3385. ISSN 2168-6068.
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